FDA Alert on Hacking Vulnerability in Heart Defibrillators Is Wake-Up Call: Lawyers
In a scenario that could have been swiped from a spy series like “Homeland,” the U.S. Food and Drug Administration issued a safety alert last week about the vulnerability to hacking of up to 750,000 implantable heart defibrillators used to correct life-threatening arrhythmias, raising novel considerations for in-house and outside counsel.
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Jeffrey Rosenthal, a partner at Blank Rome in Philadelphia who specializes in privacy and consumer protection class action defense, said on Tuesday: “It is clear that Medtronic is working with the FDA and it seems like a very upfront discussion of the issues. …Getting out ahead of this as Medtronic appears to have done appears to be a reasonable approach.”
Rosenthal pointed out that California legislation, AB 1906 and SB 327, taking effect next year regulating the internet of things will require security and privacy in devices, as would legislation under consideration in both houses of Congress. “It is indicative of our time as this is becoming more and more prevalent an issue as IoT devices become more and more a part of our modern existence,” Rosenthal said.
"FDA Alert on Hacking Vulnerability in Heart Defibrillators Is Wake-Up Call: Lawyers," by MP McQueen was published in Corporate Counsel on March 28, 2019.